The European Compliance Academy (ECA) is announcing the revised ECA Good
Practice Guide: "FDA cGMP, EU GMP and ISO 9001 Matrix for a
pharmaceutical Quality System - A GMP Roadmap".

The Matrices help answer one of the essential questions within the
framework of GMP harmonisation: Where exactly are the common traits and
differences of EU GMP, US-FDA cGMP und ISO 9001? That is the question
asked by globally operating companies that have to implement all three
regulations.

The revised ECA Good Practice Guide is a comprehensive juxtaposition
containing the requirements laid down in FDA's cGMP Guide, the EU GMP
Guide and ISO 9001.

The Revision was necessary to consider the changes and amendments of
the EU GMP Guide in the past months and to address the industry demand for
the guidance document, e.g.:

The second edition contains the EC GMP Guide in the new structure
(Part I - Basic Requirements for Medicinal Products and Part II -
Basic Requirements for Active Substances used as Starting Materials)

For globally operating pharmaceutical companies, it is mandatory to
fulfil both the requirements of the EU GMP Guide and those of FDA's cGMP
Guide. Therefore, the FDA/EU GMP Matrix compares the FDA cGMP Guide with
the EU GMP Guideline, taking the first document as a starting point. Here,
each paragraph with all its subsections (usually a), b), c) etc.) is
considered in order to maximise the informational value.

2. GMP/ISO 9001 Matrix

When publishing the Guidance for Industry "Quality System Approach
to Pharmaceutical cGMP" on 29 September 2004, the FDA took
requirements from the ISO 9001 document on "Quality Management
Systems" into account in the field of pharmaceutical manufacture. The
Guide does reference ISO 9001 and include a recommendation; however, the
outline does only focus on a partial comparison between the cGMP Guide and
ISO 9001. The ISO standard contains additional information on building up
quality management systems. In our GMP/ISO 9001 Matrix, each paragraph of
the cGMP Guide is linked to the corresponding passage in ISO 9001.

Both Matrices are linked with each other in one document. The following
screenshot shows you the structure:

The
above-mentioned Matrix is part of the ECA Good Practice Guide: "FDA
cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A
GMP Roadmap". The Good Practice Guide includes the Matrix as well as
the complete texts of the FDA cGMP Guide (21 CFR 210/211), the EU GMP
Guide and ISO 9001.

This Matrix has 20 pages as well as further 390 pages for the
three regulations. The regulations have been licensed by the respective
organisations.

Please note: The PIC/S Guide included has the same contents as
the EC GMP Guide. However, Annex 16 is not integrated, since it has not
been passed by PIC/S.

The Matrix can be ordered from ECA for EUR 149
(Non-ECA Members) or EUR 99 (ECA Members). These prices exclude VAT,
postage and packing. If you would like to purchase a copy of the GMP Matrix, please
click on one of the following links to place an order:

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